What are FDA and CDC doing to investigate?
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to monitor reports to the Vaccine Adverse Event Reporting System (VAERS) and encourage reporting of any cases of GBS after Menactra to VAERS. CDC’s Vaccine Safety Datalink and other databases are being queried to identify any cases of GBS after Menactra. Other types of studies to further evaluate the risk are planned. Because GBS is very rare, scientific study of this issue is challenging and requires extremely large databases. CDC is also communicating with and obtaining input into the investigation from the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the National Vaccine Advisory Committee about this investigation.
